Association for Molecular Pathology (AMP)

What an important day for molecular pathology and all of the patients in the United States who rely upon molecular testing to guide and improve their care. Thank you Association for Molecular Pathology (AMP) for being one of the few professional organizations brave enough to lead this fight.

Some key text in Judge Jordan's 51-page opinion in favor of Association for Molecular Pathology (AMP) and American Clinical Laboratory Association's suits against the FDA that led to the Court vacating the Final Rule for LDTs -- Essentially, the Court found that the FDA "has no authority to alter or expand the FDCA (1938 Food Drug and Cosmetics Act)'s definition of "device" -- only Congress can change the text. Also, the FDA overreached when conflating test kits manufactured for commercial distribution and professional services that involve providing a test result for clinical care -- and the Court astutely argued that under this distorted logic, virtually the entire practice of medicine would constitute "manufacturing a medical device" and thus fall under FDA oversight. #regulation #fda #molecularpatholoy #moleculardiagnostics #precisionmedicine

Today was a win for patients. The decision for Association for Molecular Pathology (AMP) and Dr. Laposada to sue the FDA because of the FDA’s Final Rule to regulate Laboratory Devloped Tests has been supported by the ruling that was released today. The massive innovation in diagnostic testing since the 2013 supreme court decision overturning gene patents almost always started with a Laboratory Developed Test. Our patients benifit from these tests every day, and thanks to the efforts of AMP staff, volunteers, Dr. Laposada, and their amazing legal team, we can continue to provide the best and most appropriate medical care to them. AMP continues to advocate for appropriate adjustments to the long-standing regulatory schemes that have enabled laboratories to provide accurate and appropriate laboratory data to patients, and we look forward to continuing those discussions in the coming months and years.

⚖️ AMP v. FDA DECISION REACHED TODAY!! ⚖️ Judge Sean Jordan ruled in FAVOR of Association for Molecular Pathology (AMP) & Dr. Michael Laposata!! 🥳🎉🎉 The #FDA final rule that sought to regulate #LDTs as medical devices has been VACATED and SET ASIDE by the Eastern District Court of Texas. You can read the Final Judgement below. This decision will allow labs to continue to operate under #CLIA and protect patient access to all lab testing! 👏 👏 👏 #CLIAclarification #LDPs #labs #diagnosticsregulation #AMPvFDA https://lnkd.in/eDmfH4kR

Today, we celebrate a significant win for patients, laboratories and the future of molecular diagnostics! The U.S. District Court has ruled in favor of the Association for Molecular Pathology (AMP), thwarting the FDA’s attempt to impose unnecessary regulations on laboratory-developed testing procedures (LDTs). If it had been left in place, the FDA’s final rule would have classified LDTs as medical devices, creating unwarranted regulatory roadblocks that could have increased costs, hindered innovation and limited patient access to critical diagnostic tools. Importantly, this ruling reinforces the vital role of laboratory professionals in driving advancements in precision medicine. We’re proud of our legal team and grateful to our members and supporters who have stood with us in this fight. While the FDA may choose to appeal, AMP remains committed to ensuring that policies support, rather than hinder, medical progress and patient care, and we’ll continue to advocate on your behalf in every way that we can. Thank you to everyone who contributed to this effort — this win belongs to all of us! Stay tuned for updates as we continue pushing for a future in which innovation yields high-quality, accessible diagnostics. Read our press release: https://lnkd.in/eedW7upH Read the ruling: https://lnkd.in/eBuRzUEA Read the opinion: https://lnkd.in/eMBu2DFx

#ArticleinPress: New Resources to Identify Characterized DNA Reference Materials for PGx and HLA Testing: The Genetic Testing Reference Material (GeT-RM) Program PGx Search Tool and GeT-RM Consolidated PGx and HLA Table. Authors from Coriell Institute for Medical Research, Children's Mercy Kansas City, RPRD Diagnostics, Medical College of Wisconsin, Mayo Clinic, Indiana University School of Medicine, Agena Bioscience and the Centers for Disease Control and Prevention. Full text: https://lnkd.in/dGYr8GD4

Today's the last day to secure early-bird pricing on our live online Molecular Genetic Pathology Review Course coming up in May! This course will include didactic lectures, case studies, live question-and-answer sessions and in-depth discussions. Learn more and register: https://lnkd.in/gwuttjka

I’m honored to be part of the inaugural AMP Middle East meeting, where I’ll be sharing insights on in silico mutagenesis and clinical bioinformatician's role in molecular diagnostics this April in Abu Dhabi. Let’s connect and learn together! Details & registration here: https://lnkd.in/g6izzWHb #AMPMiddleEast25

Just a few days left to get early-bird price for our 2025 Molecular Genetic Pathology Review Course, which will be held live online May 12–16. Register by Monday to get the best deal! Why take the course? ➤ Prepare for the MGP Subspecialty Certification Exam and other molecular pathology/genetics exams. ➤ Strengthen knowledge of fundamental and applied molecular pathology, including key assays and disease mechanisms. ➤ Understand molecular approaches for diagnosing and prognosing inherited diseases, solid/soft tissue tumors and hematopathology. ➤ Explore molecular genetic testing for infectious diseases and DNA identity testing. ➤ Gain insights into pharmacogenetics and cytogenetics for personalized medicine applications. ➤ Earn up to 34 hours of CME/CMLE credits. See the faculty and schedule: https://lnkd.in/gwuttjka

Don’t miss out on the first AMP Middle East! Join us for an unforgettable experience filled with cutting-edge insights, interactive sessions, and networking with the best in molecular diagnostics. Be part of the future—see you in Abu Dhabi!